Strand Diagnostics, LLC, maker of the know error® system for prostate biopsies, is to launch a new system designed to protect breast biopsy patients from inaccurate diagnosis due to misidentification of biopsy samples.

The know error® system for breast biopsies compares the DNA profile of the breast biopsy specimen to a reference sample taken via cheek swab. This simple process safeguards patients from misidentification errors that may occur during the complex diagnostic testing cycle for cancer. Currently, the test is available at breast centers in select areas including The Norma F. Pfriem Breast Care Center, affiliated with the Yale New Haven Health System in Bridgeport, Conn. and the Center for Breast Care, Inc., led by Dr. Deanna Attai in Burbank, Calif.

It is widely known that breast cancer is the second most common cancer among women in the United States. However, many patients and physicians are unaware that the process of collecting and evaluating the biopsy specimens used to render these cancer diagnoses involves nearly 20 steps and several medical professionals working in different locations. With such a complex process executed at a large scale, the risk of patient misidentification, specimen transposition or foreign cell contamination occurring in clinical or anatomical pathology is an ongoing concern. If left undetected, these mistakes can lead to misdiagnoses and adverse patient outcomes.

"The possibility of a misidentification of a patient's biopsy results is nothing short of catastrophic—patients are being treated for cancer that does not exist. Mastectomies, chemotherapy and radiation occurring on non-diseased tissues are completely unnecessary. In addition, potentially life-saving treatment may be delayed for the complementary patient with the false negative diagnosis," said Dr. Andrew Kenler, a Connecticut-based breast surgeon at the Norma F. Pfriem Breast Care Center. "For patients who are already faced with the prospect of a cancer diagnosis, DNA confirmation can provide a peace of mind for the patient and provider—an assurance that every patient deserves."

To prevent biopsy misidentification and enhance diagnostic accuracy and patient safety, Strand Diagnostics developed the know error® system. This innovative system uses patient-specific bar coding and forensic chain-of-custody principles for the purpose of reducing errors, and DNA testing (also known as DNA Specimen Provenance Assignment or "DSPA" testing) for the purpose of identifying errors before adverse patient outcomes occur. The DSPA test verifies patient identity at the molecular level by comparing genetic profiles obtained from the patient's biopsy tissues and a DNA reference sample, taken via cheek swab at the time of the biopsy procedure. Through these combined features, the know error® system ensures that surgical biopsy samples being evaluated belong exclusively to the patient being diagnosed, allowing physicians to proceed confidently with treatment recommendations.

"Having conducted prospective DSPA testing on tens of thousands of patients since 2009, we've seen that approximately one in every one hundred surgical biopsies are subject to patient misidentification, mislabeling or specimen contamination," said Ken Cerney, president of Strand Diagnostics. "The consequences of these mistakes are life-changing and avoidable. Every breast surgeon, radiologist and pathologist should be providing their patients with the best care possible—that means eliminating this risk."

Dr. Kenler was among the first physicians to incorporate the know error® system as a standard part of his breast biopsy protocol. He added, "Since implementing the know error® system for breast biopsies, we can be certain that we are making treatment recommendations with the most accurate information possible for our patients. With widespread adoption of DSPA testing, physicians can mitigate the risk of providing a patient with an inaccurate diagnosis and unnecessary treatment."

First developed for the urology community to verify specimen identity among prostate cancer patients, the know error® system is now available specifically for breast biopsy. For more detailed information about the know error® system, please click on the ‘request information’ tab below.